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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03625037
Registration number
NCT03625037
Ethics application status
Date submitted
7/06/2018
Date registered
10/08/2018
Date last updated
4/06/2024
Titles & IDs
Public title
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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Scientific title
A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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Secondary ID [1]
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2017-001748-36
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Secondary ID [2]
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GCT3013-01
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Universal Trial Number (UTN)
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Trial acronym
EPCORE™ NHL-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
DLBCL
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High-grade B-cell Lymphoma (HGBCL)
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Primary Mediastinal Large B-cell Lymphoma (PMBCL)
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FL
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MCL
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Small Lymphocytic Lymphoma (SLL)
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Marginal Zone Lymphoma (MZL)
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Condition category
Condition code
Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Epcoritamab
Experimental: Epcoritamab - Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
Other interventions: Epcoritamab
Administered as specified in the treatment arm.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose-Escalation: Dose Limiting Toxicity (DLT)
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Assessment method [1]
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To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
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Timepoint [1]
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During the first cycle (28 days) in each Dose-OPT Part DLBCL, FL and MCL
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Primary outcome [2]
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Dose-Escalation: Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
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Timepoint [2]
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From first dose until the end of the safety follow-up period (Up to 1 year)
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Primary outcome [3]
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Expansion and Dose-OPT MCL: Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria as assessed by independent review committee (IRC).
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Timepoint [3]
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Up to 1.5 years
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Primary outcome [4]
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Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
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Assessment method [4]
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CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
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Timepoint [4]
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From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)
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Secondary outcome [1]
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Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
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Assessment method [1]
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Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).
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Timepoint [1]
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Up to 1 year
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Secondary outcome [2]
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Dose-Escalation: DOR
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Assessment method [2]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier as assessed by the investigator.
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Timepoint [2]
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Up to 1 year
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Secondary outcome [3]
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Expansion: DOR
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Assessment method [3]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by IRC.
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Timepoint [3]
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Up to 1.5 years
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Secondary outcome [4]
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Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
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Assessment method [4]
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Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
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Timepoint [4]
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Up to 1.5 year
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Secondary outcome [5]
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Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
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Assessment method [5]
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CRS will be graded based on ASTCT criteria.
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Timepoint [5]
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Up to 1.5 years
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Secondary outcome [6]
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Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
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Assessment method [6]
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CRS will be graded based on ASTCT criteria.
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Timepoint [6]
0
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Up to 1.5 years
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Secondary outcome [7]
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Dose-OPT DLBCL and FL: ORR
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Assessment method [7]
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ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
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Timepoint [7]
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Up to 1.5 years
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Secondary outcome [8]
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Dose-OPT DLBCL and FL: CR Rate
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Assessment method [8]
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CR rate is defined as the percentage of participants with CR assessed by investigator.
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Timepoint [8]
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Up to 1.5 years
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Secondary outcome [9]
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Dose-OPT DLBCL and FL: Duration of CR (DoCR)
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Assessment method [9]
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DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.
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Timepoint [9]
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Up to 1.5 years
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Secondary outcome [10]
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Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
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Assessment method [10]
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PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.
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Timepoint [10]
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Up to 1.5 years
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Secondary outcome [11]
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Dose-OPT DLBCL and FL: DLT
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Assessment method [11]
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To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.
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Timepoint [11]
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During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
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Secondary outcome [12]
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Dose-OPT MCL: Time to Complete Response (TTCR)
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Assessment method [12]
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TTCR is defined as the time from Day 1 of Cycle 1 to first documentation of complete response based on Lugano criteria and LYRIC as assessed by IRC.
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Timepoint [12]
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Up to 1.5 years
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Secondary outcome [13]
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Dose-OPT DLBCL, FL and MCL: DOR
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Assessment method [13]
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DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.
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Timepoint [13]
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Up to 1.5 years
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Secondary outcome [14]
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Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab
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Assessment method [14]
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Timepoint [14]
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Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days)
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Secondary outcome [15]
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Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
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Assessment method [15]
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PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on Lugano criteria assessed by IRC.
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Timepoint [15]
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Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
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Secondary outcome [16]
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Expansion and Dose-OPT MCL: CR Rate
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Assessment method [16]
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CR rate is defined as the percentage of participants with CR based on Lugano criteria as assessed by IRC.
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Timepoint [16]
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Up to 1.5 years
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Secondary outcome [17]
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Expansion and Dose-OPT MCL: DoCR
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Assessment method [17]
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DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on Lugano criteria as assessed by IRC.
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Timepoint [17]
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Up to 1.5 years
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Secondary outcome [18]
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Expansion and Dose-OPT MCL: ORR
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Assessment method [18]
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ORR is defined as the percentage of participants achieving CR or PR based on lymphoma response to immunomodulatory therapy criteria (LYRIC) as assessed by IRC.
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Timepoint [18]
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Up to 1.5 years
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Secondary outcome [19]
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Expansion and Dose-OPT MCL: Time to Response (TTR)
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Assessment method [19]
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TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on Lugano criteria as assessed by IRC.
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Timepoint [19]
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Up to 1.5 years
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Secondary outcome [20]
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Expansion and Dose-OPT MCL: CR Rate
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Assessment method [20]
0
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CR rate is defined as the percentage of participants with CR based on LYRIC as assessed by IRC.
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Timepoint [20]
0
0
Up to 1.5 years
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Secondary outcome [21]
0
0
Expansion and Dose-OPT MCL: PFS
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Assessment method [21]
0
0
PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on LYRIC assessed by IRC.
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Timepoint [21]
0
0
Up to 1.5 years
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Secondary outcome [22]
0
0
Expansion and Dose-OPT MCL: DOR
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Assessment method [22]
0
0
DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on LYRIC assessed by IRC.
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Timepoint [22]
0
0
Up to 1.5 years
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Secondary outcome [23]
0
0
Expansion and Dose-OPT MCL: DoCR
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Assessment method [23]
0
0
DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on LYRIC as assessed by IRC.
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Timepoint [23]
0
0
Up to 1.5 years
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Secondary outcome [24]
0
0
Expansion and Dose-OPT MCL: TTR
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Assessment method [24]
0
0
TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on LYRIC as assessed by IRC.
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Timepoint [24]
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0
Up to 1.5 years
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Secondary outcome [25]
0
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Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
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Assessment method [25]
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0
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
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Timepoint [25]
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Up to 7 years and 6 months
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Secondary outcome [26]
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Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
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Assessment method [26]
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MRD is defined as percentage of participants with at least 1 MRD negative result.
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Timepoint [26]
0
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Up to 1.5 years
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Secondary outcome [27]
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All Parts: Number of Participants with CRS Events
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Assessment method [27]
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CRS will be graded based on ASTCT criteria.
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Timepoint [27]
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Up to Day 1 of Cycle 12 (Cycle length=28 days)
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Secondary outcome [28]
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All Parts: Immunophenotyping for Absolute T-cell and B-cell
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Assessment method [28]
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Number of cells will be reported for absolute T-cells and B-cells.
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Timepoint [28]
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Up to Day 1 of Cycle 12 (Cycle length=28 days)
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Secondary outcome [29]
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All Parts: T-Cell Activation and Exhaustion Marker
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Assessment method [29]
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T-Cell Activation and Exhaustion Marker (CD69, CD25, and PD-1) will be measured using flow cytometry.
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Timepoint [29]
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Up to 7 years and 6 months
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Secondary outcome [30]
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All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL)
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Assessment method [30]
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0
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Timepoint [30]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
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Secondary outcome [31]
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All Parts: Area under Curve (AUC) of Epcoritamab
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Assessment method [31]
0
0
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Timepoint [31]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
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Secondary outcome [32]
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All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab
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Assessment method [32]
0
0
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Timepoint [32]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
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Secondary outcome [33]
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All Parts: Time to Reach Cmax of Epcoritamab
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Assessment method [33]
0
0
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Timepoint [33]
0
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
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Secondary outcome [34]
0
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All Parts: Half Life of Epcoritamab (t1/2)
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Assessment method [34]
0
0
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Timepoint [34]
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Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
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Secondary outcome [35]
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All Parts: Number of Participants with Anti-drug Antibody (ADA)
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Assessment method [35]
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Plasma samples will be screened for antibodies binding to epcoritamab, and for confirmed positive samples, the titer against the two specific arms of epcoritamab will be reported.
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Timepoint [35]
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Up to 7 years and 6 months
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Secondary outcome [36]
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All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
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Assessment method [36]
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TTNT is defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.
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Timepoint [36]
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Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
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Secondary outcome [37]
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All Parts: Overall survival (OS)
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Assessment method [37]
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OS is defined as the time from Day 1 of Cycle 1 to death.
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Timepoint [37]
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Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years
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Eligibility
Key inclusion criteria
Main Inclusion Criteria - Escalation Part (recruitment completed)
- Documented CD20+ mature B-cell neoplasm
1. DLBCL - de novo or transformed
2. HGBCL
3. PMBCL
4. FL
5. MCL
6. SLL
7. MZL (nodal, extranodal or mucosa associated)
- Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal
antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed
after autologous stem cell rescue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
- Participants must have measurable disease by CT, MRI or Positron emission
tomography-Computed tomography (PET-CT) scan
- Acceptable renal function.
- Acceptable liver function.
Main Inclusion Criteria - Expansion & Dose-OPT Parts
- Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
- DLBCL, de novo or transformed (including double hit or triple hit).
- PMBCL
- FL grade 3B
- Histologic confirmed FL
- MZL
- SLL
- MCL (prior BTKi or intolerant to BTKi)
- At least 2 therapies including an anti-CD20 monoclonal antibody containing
chemotherapy combination regimen.
- Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or
ineligible for autologous stem cell transplantation due to age or comorbidities.
- At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement
of 2 or more clearly demarcated lesions and or nodes.
Main
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria - All Parts
- Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at
screening.
- Known past or current malignancy other than inclusion diagnosis.
- AST, and/or ALT >3 × upper limit of normal.
- Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to
Gilbert's syndrome or of non-hepatic origin.
- Estimated Creatinine clearance (CrCl) <45 mL/min.
- Known clinically significant cardiovascular disease.
- Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
requiring systemic treatment (excluding prophylactic treatment). Past COVID-19
infection may be a risk factor.
- Confirmed history or current autoimmune disease or other diseases resulting in
permanent immunosuppression or requiring permanent immunosuppressive therapy.
- Seizure disorder requiring therapy (such as steroids or anti-epileptics).
- Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20.
- Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days
prior to first epcoritamab administration.
- Eligible for curative intensive salvage therapy followed by high dose chemotherapy
with HSCT rescue.
- Autologous HSCT within 100 days prior to first epcoritamab administration, or any
prior allogeneic HSCT or solid organ transplantation.
- Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection).
Participants with evidence of prior HBV but who are PCR-negative are permitted in
- Known human immunodeficiency virus (HIV) infection.
- Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed
consent form (ICF).
- Pregnancy or breast feeding.
- Participant is known or suspected of not being able to comply with the study protocol
or has any condition for which, participation would not be in the best interest of the
participant.
- Contraindication to all uric acid lowering agents.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
666
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Health - Clayton
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Recruitment hospital [2]
0
0
Concord Hospital - Concord
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Recruitment hospital [3]
0
0
St. Vincent Hospital - Fitzroy
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Recruitment hospital [4]
0
0
Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [5]
0
0
Royal Hobart Hospital RHH - Hobart
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Recruitment hospital [6]
0
0
St. George Hospital - Kogarah
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Recruitment hospital [7]
0
0
Cabrini Hospital - Malvern
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Recruitment hospital [8]
0
0
Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [9]
0
0
Gold Coast Hospital - Southport
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Recruitment hospital [10]
0
0
Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
0
0
- Clayton
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Recruitment postcode(s) [2]
0
0
- Concord
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Recruitment postcode(s) [3]
0
0
- Fitzroy
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Recruitment postcode(s) [4]
0
0
- Herston
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Recruitment postcode(s) [5]
0
0
- Hobart
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Recruitment postcode(s) [6]
0
0
- Kogarah
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Recruitment postcode(s) [7]
0
0
- Malvern
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Recruitment postcode(s) [8]
0
0
- Nedlands
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Recruitment postcode(s) [9]
0
0
- Southport
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Recruitment postcode(s) [10]
0
0
- Sydney
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Iowa
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Michigan
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Nebraska
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New Jersey
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Ohio
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Oregon
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Pennsylvania
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Rhode Island
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Country [14]
0
0
United States of America
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State/province [14]
0
0
South Carolina
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Texas
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Country [16]
0
0
Canada
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State/province [16]
0
0
Calgary
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Country [17]
0
0
Canada
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State/province [17]
0
0
Toronto
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Country [18]
0
0
Denmark
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State/province [18]
0
0
Copenhagen
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Country [19]
0
0
Denmark
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Essen
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Alessandria
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Italy
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Italy
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Italy
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Milan
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Seoul
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Netherlands
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Navarra
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Spain
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Madrid
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Manchester
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United Kingdom
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Genmab
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Ethics approval
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Summary
Brief summary
The purpose of this trial is to measure the following in participants with relapsed and/or
refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and
GEN3013 (DuoBody®-CD3xCD20):
- The dose schedule for epcoritamab
- The side effects seen with epcoritamab
- What the body does with epcoritamab once it is administered
- What epcoritamab does to the body once it is administered
- How well epcoritamab works against relapsed and/or refractory B-cell lymphoma
The trial consists of 3 parts:
- a dose-escalation part [Phase 1, first-in-human (FIH)]
- an expansion part (Phase 2a)
- a dose-optimization part (OPT) (Phase 2a)
The trial time for each participant depends on which trial part the participant enters:
- For the dose-escalation part, each participant will be in the trial for approximately 1
year, which is made up of 21 days of screening, 6 months of treatment (the total time of
treatment may be different for each participant), and 6 months of follow-up (the total
time of follow-up may be different for each participant).
- For the expansion and dose-OPT parts, each participant will be in the trial for
approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment
(the total time of treatment may be different for each participant), and 6 months of
follow-up (the total time of follow-up may be different for each participant).
Participation in the study will require visits to the sites. During the first month,
participants must visit every day or every few days, depending on which trial part the
participant enters. After that, participants must visit weekly, every other week, once a
month, and once every 2 months, as trial participation ends.
All participants will receive active drug, and no participants will be given placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03625037
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Contacts
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Genmab
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03625037
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